BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 2393612 · Received January 2, 2012

    Report

    Report Number
    2050012-2011-08605
    Event Type
    Malfunction
    Date Received
    January 2, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 1, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE COVER ITSELF (AND THE GAS SPRINGS) HAVE AN ADDITIONAL LOCKING BRACKET WHERE ONCE THE COVER IS OPENED, WHEN PROPERLY ACTIVATED, PREVENTS A CRASHING DOWN OF THE COVER IN THE EVENT OF INADEQUATE STRENGTH OF THE SPRINGS. THE USER IS CAUTIONED IN THE USER GUIDE TO MAKE SURE THE LOCKS ARE IN PLACE WHEN OPENING THE COVER. HOWEVER, THE COVERS SHOULD NOT BE OPENED TO REMOVE OR INSERT RACKS INTO THE SYSTEM. THE OPERATOR VIOLATED THE INTENDED USE OF THE SYSTEM. THE OPERATOR DISREGARDED THE SAFETY INSTRUCTIONS AND WARNINGS GIVEN IN THE BEC IFU (INSTRUCTIONS FOR USE) MANUAL AS WELL AS THE TWO SAFETY LABELS ON THE COVER OF THE AUTOMATE SYSTEM AND DID NOT OPERATE THE SYSTEM AS SPECIFIED: IFU TELLS NOT TO REACH INTO THE DEVICE FOR LOADING/UNLOADING TRAYS. LOADING/UNLOADING TRAYS IS ONLY TO DO WITH CLOSED COVERS ON FULLY EXTENDED DRAWERS, COVERS ARE ONLY NEEDED TO BE OPENED IN CASE OF FAILURE WHICH NEEDS USER INTERACTION AND FOR CLEANING PURPOSE, THE NORMAL STATE OF THE COVERS IS CLOSED, ADDITIONALLY THE STICKER ON THE COVER ITSELF TELLS THE USER TO MAKE SURE THE COVER STAYS IN UP POSITION BEFORE REACHING INTO THE DEVICE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND PERFORMED TROUBLESHOOTING ON THE SYSTEM. THE FSE REPLACED BOTH GAS SPRINGS. PARTS WERE NOT AVAILABLE FOR ANY FURTHER INVESTIGATION. THE FSE ALSO INFORMED THE CUSTOMER TO NOT VIOLATE THE IFU AND THE SAFETY STICKERS ON THE COVER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT DURING THE LOADING/UNLOADING PROCESS OF THE AUTOMATE 2500 HS S3I (SORTER AND ALIQUOTER) SYSTEM WITH TUBE RACKS THE COVER UNEXPECTEDLY CLOSED AND STRUCK THE OPERATOR ON THE HEAD. THE OPERATOR WAS HIT ON THE FOREHEAD AND ENDURED A HEAD CONTUSION (NO CUT, NO BRUISE, SLIGHT BUMP ON THE HEAD). NO MEDICAL INTERVENTION WAS NECESSARY. THE CUSTOMER INDICATED THAT THE ANALYZER WAS FITTED WITH OLD GAS SPRINGS, WHICH MAY BECOME WORN AND DETERIORATE OVER TIME. IT IS UNKNOWN WHETHER THE GAS SPRINGS ON THE COVER WERE THE ORIGINAL ONES OR HAD ALREADY BEEN REPLACED IN THE SYSTEMS HISTORY. NO PATIENT SAMPLES WERE INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LAB AUTOMATION SYSTEM CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 2500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1